Healthy Choices Intervention to Address Stigma, Alcohol Use, and Self-Management in Spanish-Speaking Young People...

Young people with HIV experience disproportionately poor outcomes across the HIV care continuum, high levels of stigma, and elevated alcohol and other substance use. Healthy Choices is a 4-session intervention that integrates motivational interviewing with brief cognitive-behavioral strategies and has demonstrated a positive impact on HIV stigma, alcohol use, depression, and viral load in prior trials among young people with HIV. Interventions such as Healthy Choices have the potential to improve the HIV care continuum in Caribbean settings. However, no interventions have been adapted in Spanish and pilot-tested to concurrently address stigma, mental health, alcohol use, and viral burden among young people with HIV in the Dominican Republic.

This study aims to adapt Healthy Choices for Spanish-speaking young people with HIV in the Dominican Republic and pilot-test the adapted intervention with implementation strategies to assess feasibility, acceptability, and a directional signal of its potential impact.

Guided by the exploration, preparation, implementation, and sustainment framework and the health stigma and discrimination framework, this 36-month study has 3 specific aims. In aim 1, we will conduct focus groups with community representatives and in-depth interviews with young people with HIV to identify barriers, adaptation needs, and implementation strategies. In aim 2, we will use assessment, decision, adaptation, production, topical experts, integration, training, and testing and co-design workshops with community partners and a youth advisory board to contextually translate and adapt Healthy Choices for the Dominican Republic in Spanish, and we will train peer navigators. In aim 3, we will conduct a pilot randomized controlled trial with 45 young people with HIV using a 2:1 allocation to the adapted Healthy Choices intervention (n=30, 67%) or a time-attention control condition (n=15, 33%). Primary outcomes are feasibility and acceptability. Secondary and exploratory outcomes include antiretroviral adherence, viral load, alcohol and other substance use, social support, positive affect, coping, depression, and HIV-related stigma, which will be assessed from baseline to follow-up.

The study period is from March 1, 2026, to February 28, 2029. At the time of manuscript preparation, formative partnership development and key-informant consultation had been completed. The study is positioned to proceed through qualitative exploration, intervention adaptation, peer navigator training, and pilot testing across the 36-month project period. Results from the pilot trial are expected after completion of follow-up assessments.

This protocol describes an implementation science-guided approach to adapting and testing a promising intervention for young people with HIV in a high-priority global setting with translational potential for Spanish-speaking populations in the United States. If the intervention is feasible and acceptable, the study will yield preliminary data for a future full-scale hybrid type 1 effectiveness-implementation trial.

ClinicalTrials.gov NCT07638618; https://tinyurl.com/5fsdn4fj.

PRR1-10.2196/103611.